Change Control according to GxP and GMP Requirements 2019

Change Control according to GxP and GMP Requirements 2019 is a workshop dedicated to regulatory expectations from the FDA, EU and ICH perspective.

Topics

• The required components of a thorough Change Control record
• Interpret the requirements of the FDA, EU and ICH guidelines regarding compliant Change Control records
• Elements of effective Change Control management:

Who should Attend

• Documentation Department Management and Staff
• Quality Assurance Department Management and Staff
• Records Managers
• Manufacturing Department Management and Staff
• Compliance Department Management and Staff
• Document Control Management and Staff
• IT/Software Department Management and Staff
• Medical Affairs Management and Staff
• Laboratory Management and Staff
• Clinical Management and Staff